- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02080936
Does Muscle Wasting Always Mean Muscle Weakness? A Prevalence Study in COPD (M2W)
March 6, 2014 updated by: 5 Santé
Peripheral muscle mass and strength are relevant indicators of COPD survival.
Current guidelines recommend to assess muscle strength only in muscle wasted patients.
However, a recent study reported quadriceps weakness without muscle wasting (Menon, M et al.
Resp.
Res.2012, 13:119).
Thus, these guidelines raise the risk to miss out some weak patients.
In clinical settings, fat-free-mass index (FFMI) is indicated as a simple index to assess muscle wasting.
We aimed at determining the prevalence of patients entering in pulmonary rehabilitation (PR) a priori not eligible for muscle strength evaluation given the lack of muscle wasting clinical signs.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
138
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Lodeve, France, 34700
- Clinique du Souffle La Vallonie
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
COPD patients from "Clinique du Souffle La vallonie" and "Clinique du Souffle La Solane"
Description
Inclusion Criteria:
- Patients who have got FFMI (bioimpedance)
- Patients who have done quadriceps muscle strenght evaluation
Exclusion Criteria:
- Patients without FFMI
- Patients without quadriceps muscle strenght
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Muscle wasting in COPD patient
Time Frame: baseline
|
baseline
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Muscle weakness in COPD patient
Time Frame: baseline
|
baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2014
Primary Completion (Actual)
March 1, 2014
Study Completion (Actual)
March 1, 2014
Study Registration Dates
First Submitted
March 5, 2014
First Submitted That Met QC Criteria
March 6, 2014
First Posted (Estimate)
March 7, 2014
Study Record Updates
Last Update Posted (Estimate)
March 7, 2014
Last Update Submitted That Met QC Criteria
March 6, 2014
Last Verified
March 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FVIE_M2W
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.